Status:
TERMINATED
A New Micrografting Technique for Vitiligo
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Momelan Technologies
Conditions:
Vitiligo
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study evaluates micrografting using a harvesting and grafting process that has been designed by Momelan Technologies. The overall concept is to harvest several small pieces of skin, each measurin...
Detailed Description
Participants with vitiligo patches undergo removal of the epidermis of the affected vitiligo skin with dermabrasion. Several small pieces of pigmented skin (1.75mm) from the patient are taken from ano...
Eligibility Criteria
Inclusion
- Be 18 to 80 years old
- Have a diagnosis of stable vitiligo as defined by Vitiligo Disease Activity Score of 0 or 1
- Has 3 comparable vitiliginous areas of trunk or extremities (excluding hands) each measuring at least 3cm×3cm in size, with at least 80% of depigmentation, and anticipated equal sun exposure.
- Have not used any topical therapy to patches or Ultraviolet light therapy for at least 2 weeks (subjects may restart phototherapy at week 10 if desired)
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures
Exclusion
- Female patients who are breastfeeding, pregnant, or planning to become pregnant
- Patients with a history of hypertrophic scaring or keloids and psoriasis
- Subjects on any dose of coumadin, warfarin, Plavix or at least 325 mg aspirin.
- Concurrent use of immunosuppressive medications such as oral steroids, tacrolimus and other cytotoxic reagents within 2 weeks of grafting)
- Subject who received topical therapy or UV light ( phototherapy)in last 2 weeks
- Patients with a positive HIV status
- Patients withDiabetes Mellitus with a hemoglobin A1C of more than 8.
- Subjects with dermatologic conditions that may Koebnerize such as psoriasis and lichen planus.
- Participation in another interventional study with potential exposure to an investigational drug within past 30 days
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01262547
Start Date
September 1 2011
End Date
May 1 2013
Last Update
October 31 2014
Active Locations (1)
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1
Mgh Curtis
Boston, Massachusetts, United States, 02114